NCT00064233CompletedPhase 1
A Phase I Dose-Escalation Study To Determine The Safety, Pharmacokinetics, And Pharmacodynamics Of BMS-354825 In The Treatment Of Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Hematologic Resistance To Imatinib Mesylate (Gleevec
Jonsson Comprehensive Cancer Center2 sites in 1 country42 target enrollmentStarted: November 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 42
- Locations
- 2
Study Overview
Brief Summary
RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose, maximum administered dose, dose-limiting toxicity, and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate.
- Determine the safety and tolerability of this drug in these patients.
- Determine the plasma pharmacokinetics of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug, in terms of hematologic, cytogenetic, and molecular responses in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression.
Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •extramedullary involvement (other than liver or spleen)
- •significant bleeding disorder unrelated to CML
- •acquired bleeding disorder within the past year (e.g., acquired antifactor VIII antibodies)
- •congenital bleeding disorders (e.g., von Willebrand disease)
- •uncontrolled or significant cardiovascular disease
- •uncontrolled angina within the past 6 months
- •congestive heart failure within the past 6 months
- •myocardial infarction within the past 12 months
- •history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- •history of second or third degree heart block (may be eligible if patient has a pacemaker)
- •diagnosed or suspected congenital long QT syndrome
- •prolonged QTc interval on pre-entry EKG (i.e., greater than 450 msec)
- •heart rate less than 50/minute on pre-entry EKG
- •uncontrolled hypertension
- •vasculitis
- •pregnant or nursing
- •gastrointestinal tract bleeding within the past 6 months
- •connective tissue disorders
- •other serious uncontrolled medical disorder or active infection that would impair the ability to receive study therapy
- •dementia or altered mental status that would preclude giving informed consent
- •evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EKG, or clinical laboratory determinations unrelated to CML
- •prisoners or patients who are compulsorily detained (e.g., involuntary incarceration for treatment of either a psychiatric or physical [e.g., infectious disease] illness)
- •concurrent drugs accepted to have a risk of causing torsades de pointes
- •other concurrent treatment for CML
- •concurrent dolasetron or droperidol
- •concurrent anticoagulants
- •concurrent medications that inhibit platelet function
Investigators
Study Sites (2)
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